BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN., STERILE

    MDR report key: 13598674 · Received February 25, 2022

    Report

    Report Number
    1213809-2022-00100
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 11, 2022
    Report Date
    March 11, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095804
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN., STERILE FOREIGN MATTER WAS FOUND IN THE BARREL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:309580 BATCH NO: 1081263.   IT WAS REPORTED BY THE CONSUMER OILY SUBSTANCE IN THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN., STERILE FOREIGN MATTER WAS FOUND IN THE BARREL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:309580 BATCH NO: 1081263.   IT WAS REPORTED BY THE CONSUMER OILY SUBSTANCE IN THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN., STERILE FOREIGN MATTER WAS FOUND IN THE BARREL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:309580. BATCH NO: 1081263.   IT WAS REPORTED BY THE CONSUMER OILY SUBSTANCE IN THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194908 BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN., STERILE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309580 1081263 30382903095804

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown